The following data is part of a premarket notification filed by N Spine, Inc. with the FDA for Nfix Ii Pedicle Screw System.
Device ID | K061774 |
510k Number | K061774 |
Device Name: | NFIX II PEDICLE SCREW SYSTEM |
Classification | Posterior Metal/polymer Spinal System, Fusion |
Applicant | N SPINE, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
Contact | R. Stephen Reitzler |
Correspondent | R. Stephen Reitzler N SPINE, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
Product Code | NQP |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2006-06-23 |
Decision Date | 2006-12-13 |
Summary: | summary |